Nordic Luveris Study

This study has been completed.

Sponsor:

Collaborators:

Regionshospitalet Viborg, Skive

Karolinska University Hospital

Helse Fonna

Turku Hospital

Odense University Hospital

Herlev Hospital

Holbaek Sygehus

Hvidovre University Hospital

Information provided by:

Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT00553293

First received: November 2, 2007

Last updated: NA

Last verified: November 2007

History: No changes posted

Purpose

To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.

Condition	Intervention	Phase
Infertility In Vitro Fertilization	Drug: recombinant luteinizing hormone (Luveris) Drug: recombinant follicle stimulating hormone (Gonal-f)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Hormones Infertility

Drug Information available for: Luteinizing Hormone Lutropin alfa

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Ongoing pregnancy rate per started stimulation cycle [ Time Frame: ultrasound showing ongoing pregnancy ]

Secondary Outcome Measures:

Ongoing pregnancy in subgroups of patients with lo0w serum LH levels [ Time Frame: ultrasound for ongoing pregnancy in subgroups ]


Enrollment:	526
Study Start Date:	August 2003
Study Completion Date:	November 2004

Arms	Assigned Interventions
Active Comparator: A,1 rFSH + rLH arm	Drug: recombinant luteinizing hormone (Luveris) 75 iu/day form cycle day 6 Other Name: Luveris
Placebo Comparator: A,2 rFSH alone	Drug: recombinant follicle stimulating hormone (Gonal-f) rFSH 150 iu/day Other Name: Gonal-f

Eligibility


Ages Eligible for Study:	21 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age below 40
Infertility treatable by IVF or ICSI
Regular cycles

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553293

Locations


Denmark
Anders Nyboe Andersen
Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Regionshospitalet Viborg, Skive

Karolinska University Hospital

Helse Fonna

Turku Hospital

Odense University Hospital

Herlev Hospital

Holbaek Sygehus

Hvidovre University Hospital

Investigators


Principal Investigator:	Anders N Andersen, professor	Fertility Clinic, Rigshospitalet

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00553293 History of Changes
Other Study ID Numbers:	KF02-035/03
Study First Received:	November 2, 2007
Last Updated:	November 2, 2007
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:


infertility in vitro fertilization LH supplementation Benefits

Additional relevant MeSH terms:


Follicle Stimulating Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015

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